Recall Z-2285-2013— CareFusion 303, Inc.

Name: FDA recall Z-2285-2013
Creator: U.S. Food and Drug Administration
Published: 2013-08-30

Class II · Terminated

Class II FDA medical device recall by CareFusion 303, Inc., initiated 2013-08-30, terminated 2014-04-16. It names one FDA 510(k) clearance: K944320. Product: SmartSite Low Sorbing Infusion Set, Model# 10015048. Intravascular administration set.. Reason: CareFusion is recalling the SmartSite Low Sorbing Infusion Set, Model# 10015048, because there is a potential for separation at the tubing sleeve below the drip chamber..

Recalling firm: CareFusion 303, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-08-30
Terminated: 2014-04-16
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K944320 — VENTED/NON-VENTED GEMINI ADMINISTRATION SETImed Corp.·cleared 1995-02-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

SmartSite Low Sorbing Infusion Set, Model# 10015048. Intravascular administration set.

Reason for recall

CareFusion is recalling the SmartSite Low Sorbing Infusion Set, Model# 10015048, because there is a potential for separation at the tubing sleeve below the drip chamber.

Data sourced from openFDA. This site is unofficial and independent of the FDA.